Evidence map›Paper›PMID 21627828›Full record

Trial reportRespiratory research2011

Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.

Paul W Jones, Julie A Anderson, Peter Ma Calverley, Bartolome R Celli, Gary T Ferguson, Christine Jenkins, Julie C Yates, Jørgen Vestbo, Michael D Spencer, TORCH investigators

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00268216 (A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate), which is not on this map. Cited by 45 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00268216 phase3completednot on this map

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment

TypeinterventionalSponsorGlaxoSmithKlineRan2000 to 2005Enrolled6,228ConditionsPulmonary Disease, Chronic ObstructiveArmsSalmeterol 50mcg/ Fluticasone Propionate 500mcg
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  7. Long-acting beta2-agonists for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2013
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  15. Article
  16. Is Disease Stability an Attainable Chronic Obstructive Pulmonary Disease Treatment Goal?American journal of respiratory and critical care medicine · 2025
    Review
  17. Article
  18. Article
  19. Article
  20. Towards precision in defining COPD exacerbations.Breathe (Sheffield, England) · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Paul W JonesDepartment of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK. pjones@sgul.ac.uk
Julie A Anderson
Peter Ma Calverley
Bartolome R Celli
Gary T Ferguson
Christine Jenkins
Julie C Yates
Jørgen Vestbo
Michael D Spencer
TORCH investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLittle is known about factors that determine health status decline in clinical trials of COPD.

objectivesTo examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.

methodsSt George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months. MEASUREMENTS AND MAIN

resultsData from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.

conclusionsIn addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.

trial registrationClinicalTrials.gov: NCT00268216.

Indexed as

Health StatusAdrenergic beta-2 Receptor AgonistsAgedAge FactorsAlbuterolAndrostadienesAsiaBronchodilator AgentsDisease ProgressionDouble-Blind MethodDrug CombinationsEuropeFemaleFluticasoneFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeAdrenergic beta-2 Receptor AgonistsAlbuterolAndrostadienesBronchodilator AgentsDrug CombinationsFluticasoneFluticasone-Salmeterol Drug CombinationGlucocorticoidsSalmeterol Xinafoate

Identifiers

PMID21627828
PMCPMC3117702

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.